The world is changing, and clinical trials are changing with it. Our virtualization services are implemented to guide our clients through assessing, designing, deploying, and managing fit-for-purpose, agile solutions that enable hybrid or fully virtual clinical trials. We help our clients stay ahead of the game with tailored approaches that fortify their clinical trials with virtual capabilities. We call this our “Reimagined Clinical Trial”.
BROWSE OUR SERVICES
We evaluate the benefits and risks of virtualization to give our clients a clear picture of what it means to run clinical programs virtually with the patient at the forefront under a culture of quality. We align on the desired point of arrival, short- and long-term goals, and assumptions. We deliver a business case with a value proposition that can be presented to executive stakeholders for endorsement and alignment.
We incorporate Quality by Design (QbD) recommendations and facilitate design sessions with key stakeholders to drive efficiency in trial design and increase the value to the patient, caregiver, and site. These design sessions may be run at the company, portfolio, or protocol level depending on the organization’s goals. Together we generate implementation scenarios including digital endpoint assessments, patient outcome measures, virtualization and decentralized trial options. We assess our clients’ current technology, process, and resources to determine which tools, skill sets, and third-party vendors are best suited for the implemented solution.
Our deliverables include:
- Executive Summary outlining options and the change impact assessment for virtualization
- Implementation Plan across technology, process, and resourcing:
- Prioritized Set of Activities and Timelines
- Process and Document Recommendations
- Resourcing Recommendations (internal and external)
- Vendor Recommendations
- Change Management & Training Strategies
- Transition Plans
We partner with our clients to implement the technologies, processes, and resources necessary to create meaningful change for their organizations. We follow a strategic change management methodology, incorporating program leadership, role alignment, training and communication plans, and process documents where needed. We leverage our pre-qualified vendor shortlist to optimize execution.
Our deliverables include:
- Program Leadership & Governance
- Change Management (Role Alignment, RACI, Workflows, Sustaining Governance)
- Virtualization Implementation Playbook
- Selected and Qualified Vendors
- Training and Communication Plans encompassing the Sponsor, Site, and Patient Levels
- Process Documents
- Data Integration Plan including alignment of master data standards (if applicable)
- System Implementation including validation support, data migration, training, and hypercare
- Study-Specific Implementation Planning
We provide compliant, flexible virtual study management oversight, resources, and training to fit our clients’ trial needs. We bring extensive third-party vendor selection and management experience as well as a breadth of regulatory, quality, and clinical expertise to help clients identify the right vendor match, deliver studies faster than traditional CROs, and provide the oversight required to obtain high quality study results. We provide comprehensive training at the sponsor, vendor, site, and patient-levels to ensure optimal study success.
We work with our clients to align key stakeholders on the importance of harnessing and managing their data. We work with senior leadership to outline an enterprise end-to-end data strategy that includes establishing Master Data Management (MDM) governance and processes, data quality best practices, a digital endpoint strategy, stakeholder reporting governance, and continuous improvement actions based on data insights.
Our deliverables include:
- Data Literacy Training
- MDM Strategy Development
- Data Governance Framework (processes, communication channels, roles and responsibilities, accountabilities, and escalation)
- Data Migration and Integration Plans
- Streamlined System and Report Inventory with Gap Assessment
- Data Standards and Data Dictionary
We work with our clients to turn their data into insights that drive action. Using industry benchmark data and data management strategies, we tailor our clients’ reporting needs to monitor key indicators of the operational health of their studies. We recognize that there are multiple data consumers that require different levels of information and will provide a suite of automated reports and/or dashboards that include industry standard metrics and benchmarks for performance such as:
- Portfolio-Level Senior Leadership Reporting (high-level operational, quality and financial health via established KPIs, KQIs and KRIs)
- Program-Level Management Reports
- Study-Level Management Reports
- Investigator/Site-Level Reporting (comparing individual site metrics to study medians)
- Patient-Level Reporting (providing visibility into collected health information)
We combine leading and lagging indicators coupled with embedded industry performance benchmarks so clients can set clearly defined targets to measure operational and clinical data health.
We work with our clients to define the right technology-enabled risk management processes, key risk indicators (KRIs), quality tolerance limits (QTLs), and assessment/categorization tools that enable risk-based approaches across the company, program, and study levels. These processes allow for earlier detection and mitigation of risks, proactive decision making, and cost-saving operational efficiencies.
At the sponsor, program, and/or study level, we perform a risk assessment with the key stakeholders and vendors to identify the critical risks, thresholds, and mitigations for the clinical trials and new virtual options using an efficient, pre-configured risk assessment and categorization tool (RACT). We outline the risk management strategy and clear risk triage and communication processes in an integrated quality and risk management plan (IQRMP) and update functional plans as needed. We also develop and implement a risk-based monitoring (RBM) strategy/framework that fits into the risk management process.
Our deliverables include:
- Integrated Quality and Risk Management Plan (IQRMP)
- Risk Assessment and Categorization Tool (RACT) alignment across all vendors and stakeholders
- Key Risk Indicator (KRI) Library development and customization per study
- Risk-Based Monitoring strategy and framework development and implementation support
Halloran facilitates virtual or on-site inspection and audit readiness engagements, helping to prepare our clients for anticipated regulatory inspections (FDA, EMA, MHRA, PDMA, CFDA), diligence by investors, or potential partner evaluations. These engagements include inspection readiness preparedness, mock inspections and audits, storyboard preparation, behavioral interview training, and coaching. Halloran also leads clients through the immediate remediation by authoring responses including strategies for remediation and developing corrective and preventative action plans (CAPA).
There is a tendency to overcomplicate protocols, ignore risks, capture too much data, and neglect to consider the patient journey. Unnecessary burden on sites and patients can impact recruitment, retention, and the success of studies. Poorly written protocols contain unnecessary redundancies, over-complex study endpoints, and nebulous description leading to deviations, heterogenous interpretations, and uninterpretable data. Collectively these factors will reduce the quality of the data, cause protocol amendments, drive costs up, and prolong timelines.
Our clinical trial design experts can optimize the design and simplification of studies, including adoption of virtualization and patient centric strategies, to obtain the right data from the right patients as quickly and inexpensively as possible, thereby enabling key decisions to be made with the patient at the forefront.
Regulatory and clinical development is complicated enough, it’s time to leverage new technology that enables patients to participate and data to be collected more efficiently and cost effectively than ever before.
president & CEO